NCT00112190

Brief Summary

Itopride is a new compound that is already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients suffering from this condition have difficulties digesting food. They feel full after eating a few bites; they feel bloated and their stomachs hurt. The goal of this study is to see if itopride helps to relieve the symptoms of functional dyspepsia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
645

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 1, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

8 months

First QC Date

May 31, 2005

Last Update Submit

February 6, 2017

Conditions

Dyspepsia

Keywords

Functional dyspepsiaAbdominal Symptom reliefFullnessBloatingIndigestion

Outcome Measures

Primary Outcomes (1)

  • Symptom relief

Secondary Outcomes (2)

  • Impact of symptom relief on quality of life

  • Safety

Interventions

Itopride HydrochlorideDRUG

100 mg tid

itoprideDRUG

100 mg three times daily

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from functional dyspepsia according to Rome II criteria
  • years old
  • Absence of, or infrequent heartburn (one episode per week or less)
  • Helicobacter pylori (H. pylori) negative
  • Normal upper endoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AXCAN Pharma Inc.

Mont St-Hilaire, Quebec, J3H 6C4, Canada

Location

MeSH Terms

Conditions

Dyspepsia

Interventions

itopride

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicholas Talley, MD

    Mayo Clinic, Rochester, Minn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 31, 2005

First Posted

June 1, 2005

Study Start

July 1, 2004

Primary Completion

March 1, 2005

Study Completion

March 1, 2006

Last Updated

February 8, 2017

Record last verified: 2017-02

Locations

CA(1)